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FRED Retrospective Study of Intracranial Aneurysms Treatment
Sponsor: Microvention-Terumo, Inc.
Summary
To evaluate the long-term safety and efficacy of Flow Re-Direction Endoluminal Device System (FRED) in the treatment of intracranial aneurysms in the post-market environment
Official title: A Retrospective Post-Market Clinical Study of the Flow Re-Direction Endoluminal Device System in the Treatment of Intracranial Aneurysms
Key Details
Gender
All
Age Range
18 Years - 90 Years
Study Type
OBSERVATIONAL
Enrollment
2000
Start Date
2025-05
Completion Date
2027-05-06
Last Updated
2025-05-21
Healthy Volunteers
No
Conditions
Interventions
Flow Re-Direction Endoluminal Device System(FRED)
Flow Diverter (FD) devices are developed based on reconstructing the parent artery's lumen. FDs are designed with a denser mesh compared to conventional intracranial stents. By covering the aneurysm neck, these stents redirect blood flow away from the aneurysm, promoting intra-aneurysmal flow stagnation and subsequent thrombosis formation. Currently, FDs are primarily used for the treatment of wide-neck aneurysms.